Regeneron Pharmaceuticals and Sanofi announced that the European Commission (EC) has granted approval for Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils. This marks the first global approval for Dupixent in treating COPD. The approval is based on the results of two significant Phase 3 trials, BOREAS and NOTUS, which demonstrated that Dupixent significantly reduces exacerbations, improves lung function, and enhances health-related quality of life.
This approval introduces a new treatment approach for COPD, the first in over a decade, providing a new option for approximately 220,000 adults in the European Union (EU). This marks the sixth indication for Dupixent in the EU and the seventh globally. Additional regulatory submissions are under review in several other countries, including the United States, China, and Japan.
Phase 3 Trials: BOREAS and NOTUS
The EC's approval is founded on data from the BOREAS and NOTUS Phase 3 trials, which evaluated the safety and efficacy of Dupixent in adults with uncontrolled COPD and evidence of type 2 inflammation. Both trials included patients already on maximal standard-of-care inhaled therapy, with nearly all on triple therapy (inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA)).
Key findings from the trials include:
A 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks.
Significant improvements in lung function, with pre-bronchodilator FEV1 increases of 160 mL and 139 mL at 12 weeks.
Enhanced health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ).
The benefits were consistent across various subgroups, including different smoking statuses, baseline lung functions, and histories of exacerbations. Safety results from both trials were generally consistent with Dupixent's known safety profile.
COPD and Its Challenges
COPD is a progressive lung disease that leads to declining lung function and is a leading cause of death worldwide. Symptoms include persistent coughing, excessive mucus production, and shortness of breath, which can severely impact daily activities and lead to anxiety and depression. The disease imposes a significant health and economic burden due to frequent exacerbations that often require hospitalization and systemic corticosteroid treatment. Smoking and exposure to harmful particles are major risk factors, but the disease can persist even in individuals who quit smoking.
About the Trials
The BOREAS and NOTUS trials were randomized, double-blind, placebo-controlled studies involving 1,874 patients who were current or former smokers with moderate-to-severe COPD and type 2 inflammation, as indicated by blood eosinophils ≥300 cells per µL. Patients received Dupixent or placebo every two weeks, alongside their standard inhaled therapy.
Primary endpoints focused on the annualized rate of moderate or severe exacerbations, while secondary endpoints included changes in lung function and quality of life scores over 52 weeks.
Regeneron and Sanofi stated that they are exploring new treatment paradigms for COPD by investigating different types of inflammation. Dupixent targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, while another investigational drug, itepekimab, targets interleukin-33 (IL-33). Itepekimab is currently being studied in Phase 3 trials, though it has not yet been evaluated by any regulatory authority.
Dupixent, developed using Regeneron’s VelocImmune technology, is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling without being an immunosuppressant. It has demonstrated significant clinical benefits across multiple indications, reducing type 2 inflammation. Dupixent is approved in over 60 countries for various conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and now COPD. More than 900,000 patients globally are receiving treatment with Dupixent.
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